SERC 24 mg TABLETS

Introduction

Leaflet: information for the user

Serc 24 mg tablets

Betahistine (betahistine dihydrochloride)

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Serc 24 mg is and what it is used for
2. What you need to know before taking Serc 24 mg
3. How to take Serc 24 mg
4. Possible side effects
5. Storage of Serc 24 mg
6. Package contents and additional information

1. What Serc 24 mg is and what it is used for

Serc 24 mg tablets belong to a group of medications called antivertigo preparations: preparations against vertigo, and its active ingredient is betahistine dihydrochloride.

Serc 24 mg tablets are used for the treatment of Meniere's Syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and a sensation of noise inside the ear (tinnitus).

The active ingredient of this medication is a histamine analogue that acts by improving circulation in the inner ear, thereby reducing pressure. The inner ear is one of the organs responsible for the sense of balance.

2. What you need to know before taking Serc 24 mg

Do not take Serc 24 mg:

• if you are allergic to the active ingredient betahistine or to any of the other components of this medication (listed in section 6)
• if you have a type of adrenal gland cancer called pheochromocytoma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take betahistine:

• if you have bronchial asthma,
• if you have or have had stomach ulcers,
• if you suffer from skin rashes and intense itching (urticaria), skin eruptions (exanthema), or hay fever.

Patients should be carefully monitored by their doctor during treatment with this medication.

Children and adolescents

Serc 24 mg is not recommended for use in children and adolescents under 18 years of age, as there is no experience in these age groups.

Use of Serc 24 mg with other medications:

Tell your doctor or pharmacist if you are using, have recently used, or may need to use other medications, including those purchased without a prescription.

Taking this medication at the same time as antiallergic medications such as antihistamines (especially H1 antagonists) may reduce the effectiveness of both medications.

Caution is recommended when using betahistine and MAO inhibitors (including selective MAO-B inhibitors, such as selegiline) at the same time, as it may inhibit the metabolism of betahistine.

Taking this medication at the same time as monoamine oxidase inhibitors (MAOIs) (used to treat Parkinson's disease) may increase the effect of betahistine.

Use of Serc 24 mg with food and beverages:

It is recommended to take Serc 24 mg during or after meals to avoid stomach upset.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is not known whether this medication affects the fetus, so Serc 24 mg should not be taken during pregnancy, unless your doctor considers it necessary.

It is not known whether this medication passes into breast milk, so if you are taking Serc 24 mg, you should not breastfeed your child.

There are no data available on the effect of this medication on fertility.

Driving and using machines

Serc 24 mg is indicated for Meniere's syndrome. This disease can negatively affect the ability to drive and use machines. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistine had no effects or they were insignificant.

Serc 24 mg contains lactose:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Serc 24 mg

Follow the exact instructions for administration of this medication as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The dose varies depending on the person and their response to treatment.

The recommended initial dose is 24 mg once a day.

Maximum daily dose: the patient can increase the dose to 24 mg taken twice a day (48 mg divided into two doses).

Maintenance dose: it will be established based on the response to treatment until the minimum effective dose is reached.

It is best to take the tablets with food.

Based on your response, your doctor will indicate the maintenance dose.

The effect of the medication usually does not manifest until after two weeks.

You should take Serc 24 mg for as long as your doctor recommends, so you should not stop treatment before that, as the expected results will not be achieved.

Use in children and adolescents

This medication should not be used in children and adolescents, as its safety and efficacy have not been established.

If you take more Serc 24 mg than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

You may experience the following symptoms due to an overdose: nausea, drowsiness, abdominal pain.

You may also experience rapid heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), fluid accumulation in the tissues (edema). Seizures can occur after taking very high doses. Symptomatic treatment is recommended, as there is no specific antidote.

If you forget to take Serc 24 mg:

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, wait until the next dose and continue with the normal treatment.

If you stop treatment with Serc 24 mg:

You should take Serc 24 mg for as long as your doctor recommends. You should not stop treatment before that, as the expected results will not be achieved.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During treatment with betahistine, the following serious side effects may occur:

Allergic reactions such as: swelling of the face, lips, tongue, or throat. This can cause difficulty breathing.

Red skin rash, inflammation, and itching.

If you experience any of these side effects, you should stop treatment immediately and contact your doctor.

Common side effects (may affect up to 1 in 10 people)

Headache, occasional drowsiness, nausea, indigestion, mild stomach problems such as vomiting, stomach pain, and bloating.

Taking betahistine with food may help reduce these stomach problems.

Frequency not known (frequency cannot be estimated from available data)

Itching, rash, urticaria, abnormal heartbeats (palpitations).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Serc 24 mg

Keep this medication out of the sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Serc 24 mg tablets

• The active ingredient is betahistine in the form of betahistine dihydrochloride.
• The other ingredients are: povidone K90 (E-1201), microcrystalline cellulose (E-460i), lactose monohydrate, colloidal anhydrous silica, crospovidone, and stearic acid (E-570).

Appearance of the product and package contents

Serc 24 mg tablets are presented in the form of biconvex tablets (Snap-Tab), with a score line on one face, and are white in color.

The tablets can be divided into equal doses.

Packaging of 30 or 60 tablets, in PVC/PVDC/aluminum blisters.

Other presentations:

Betahistine Qualigen 16 mg tablets. Packaging of 30 tablets.

Betahistine Qualigen 8 mg tablets. Packaging of 60 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Catalent Germany Schorndorf GmbH

Steinbeisstrasse 2, D-73614 Schorndorf

Germany

Or

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Date of the last revision of this leaflet: June 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.